1. Field of the Invention
The present invention relates generally to transfer devices for use in mixing medicinal substances. More particularly, the invention concerns a novel fluid transfer and mixing device for intermixing a fluid with a powdered medicament and for the aseptic delivery of the mixture to a patient.
2. Discussion of the Invention
Many medicinal agents intended for parenteral administration are stored in powder form in a bottle or vial under vacuum. The dry medicinal agent in powdered form typically requires reconstitution with a suitable diluent prior to administration. In the past, the diluent has been provided either in a pre-filled syringe or in a glass vial or bottle. The vial or bottle is generally closed by an elastomeric stopper which can be penetrated by a piercing member as, for example, sharp end or blunt end needle. The elastomeric stopper, which may be slit to accept a blunt end cannula, is typically self-closing upon withdrawal of the piercing member. As previously mentioned, when the drug or other beneficial agent is in powdered or lyophilized form, the vial or bottle is under a relatively high vacuum.
In the past, the medicament to be delivered to the patient has been prepared by filling a conventional syringe with an appropriate diluent. The seal of the container containing the powder is then pierced by the needle of the filled syringe and the diluent is injected into the container to intermix with the powder. The mixture thus formed is then allowed to aspirate back into the syringe so that it can be delivered to the patient in a conventional manner.
Drawbacks of this type of prior art method include the possibility of highly undesirable needlestick. Additionally, the prior art method is troublesome because of the difficulty of locating the center of the stopper or seal of the container that is to be pierced. Further, considerable skill and experience is required to withdraw the entire contents of the medicament from the container containing the mixture of the powder and the diluent so that a proper dose can be delivered to the patient.
It is vitally important that the intermixing of the diluent and the powdered agent be done under sterile conditions. Similarly, the transfer of the reconstituted medicinal agent from the vial or bottle into a suitable administration means, such as a syringe, must be done in a careful and sterile manner. The problem of ensuring such fluid transfers under aseptic conditions is especially acute in the case of self-administration of drugs by patients in a home-care environment.
A useful apparatus for accomplishing the sterile intermixing and subsequent delivery of the reconstituted beneficial agent to a patient is described in copending U.S. Ser. No. 08/913,432 filed by the present inventor. This application is hereby incorporated by reference as though fully set forth herein. One embodiment of the invention described in the incorporated-by-reference application comprises a fluid control device for the preparation of a medicament by mixing a first substance contained within a first medicinal vessel with a second substance contained in a second medicinal vessel and thereafter the transferring of the drug to a dispensing tool, namely, a syringe. A principal feature of the fluid control device of this earlier-filed application resides in the provision of a base member having a generally tubular intermediate portion defining a lumen in which a flow control member is rotatably inserted. The flow control member has a port fashioned as a female luer connector for receiving a dispensing tool such as a syringe. The flow control member includes integrally formed handles for enabling the manual rotation thereof.
As will be better understood from the description that follows, the apparatus of the present invention uniquely eliminates the flow control member found in the apparatus described in the previously filed application thereby simplifying the construction of the device and making it much easier to use and considerably less costly to manufacture. More particularly, the apparatus of the present invention uniquely comprises a greatly simplified, two component mixing device that includes first and second cooperating adapters of novel design. The first adapter, which is used to access a first container, includes a top wall, a cannula depending from the top wall and a resiliently deformable skirt connected to the top wall for telescopically receiving the upper portion of the first container that contains a powdered medicament. The second adapter of the apparatus, which is used for accessing a second container, can be readily connected to and disconnected from the first adapter. In one form of the invention, the second adapter, like the first adapter comprises a top wall, a cannula depending from the top wall and a resiliently deformable skirt connected to said top wall for telescopically receiving the upper portion of the second container that contains a diluent.
In using the apparatus of one form of the present invention, the first and second adapters are first interconnected and the assemblage thus formed is then connected to the first container containing the lyophilized or powdered medicament. Next the second, or diluent container is connected to the adapter assemblage so that the diluent can flow through the assemblage and directly into the first container where it will intermix with the powder contained therewithin. This done, the second adapter along with the diluent container is disconnected from the first adapter. With the first adapter still connected to the first container, which now contains the reconstituted medicament that is to be administered to the patient, the second container is accessed by a needleless syringe so that the mixture can be aspirated from the second container and delivered to the patient in a conventional manner using the thusly filled syringe.
Other prior art fluid control and coupler devices known to applicant include U.S. Pat. No. 4,638,975 issued to Iuchi et al; U.S. Pat. No. 4,997,420 issued to Van Der Heiden et al; U.S. Pat. No. 5,104,387 issued to Pokorney et al; and U.S. Pat. No. 5,334,163 issued to Sinnett.
It is an object of the present invention to provide a novel, easy-to-use fluid transfer and mixing device for use in the aseptic intermixing of a powder component with a fluid component.
Another object of the invention is to provide a device of the aforementioned character that is of a simple, compact construction that includes a first adapter that can be easily connected to a container containing the powder component and a second adapter that can be removably interconnected with the first adapter and can also be readily connected to a container containing a fluid such as a diluent so as to permit aseptic intermixing of the diluent with the powder.
Another object of the invention is to provide a device as described in the preceding paragraph in which a conventional needleless syringe can be easily connected to the first adapter so that the mixture of powder and diluent can be aseptically aspirated from the first container for subsequent delivery to the patient.
Another object of the invention is to provide a transfer and mixing device that includes filter means for filtering particulate matter from the mixture to be delivered to the patient.
Another object of the invention is to provide a device of the character described which both avoids needlestick and at the same time is very easy to use because the first and second adapters are designed to effortlessly and precisely snap onto and securely grip the first and second containers.
Another object of the invention is to provide a device that is uniquely designed so that, after the mixing step and upon separation of the first and second adapters by relative rotation thereof, the user is left with an adapter that is already connected to the container containing the medicament mixture to be delivered and has ready access to a luer connector provided on the adapter to which a needleless syringe can be easily connected.
Another object of the invention is to provide a device as described in the preceding paragraph that includes valving means for controlling fluid flow through the first adapter.
Another object of the invention is to provide a third transfer apparatus of the class described which is of a simple construction, can readily be used in the home care environment and one that can be inexpensively manufactured in quantity.
These and other objects of the invention are satisfied by the apparatus of the invention that will be described in the paragraphs that follow.